- DiaMedica Therapeutics ( NASDAQ: DMAC ) on Wednesday said the U.S. FDA had placed a clinical hold on its phase 2/3 trial evaluating its product candidate DM199 for the treatment of a type of stroke called acute ischemic stroke.
- The trial, called ReMEDy2, was put on hold as three serious cases of low blood pressure in stroke patients were reported after they received an injection of DM199.
- The company said it had paused patient enrollment, and believes the low blood pressure events were due to the use of a different intravenous bag in the ReMEDy2 trial from the one used in the prior ReMEDy1 trial.
- "...the company is confirming the differences in drug absorption in the IV bags used in the ReMEDy1 trial compared to the ReMEDy2 trial and plans to work with the FDA to modify the ReMEDy2 trial protocol to adjust the DM199 IV dosing to more closely match the dosing in the ReMEDy1 trial, taking into account these differences", DMAC said.
- DMAC said that no such low blood pressure issues were reported in the ReMEDy1 trial.
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FDA puts DiaMedica's phase 2/3 trial for its stroke treatment DM199 on clinical hold